The importance of informed consent in developing countries.

Fasil Tekola, M.P.H., our pre-doctoral trainee (see the July 2nd post), published last week in PLoS Neglected Tropical Diseases an important qualitative study focused on the process of informed consent in developing countries (available here). This study was part of a larger project, which aims to determine the genetic basis of susceptibility to podoconiosis using a validated clinical staging system for the disease and, of course, an appropriately designed consent process. This work highlights an important component of research carried out here at the CRGGH. Mr. Tekola's work is also recently highlighted in Wellcome Trust's July 31st edition of Science Policy and Related News (SPIN).

Mr. Tekola, along with collaborators in the United Kingdom, conclude that "researchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis". Mr. Tekola summarizes the study below:

"Informed consent to biomedical research in developing countries is a highly topical issue. When consent forms and processes are simply borrowed from developed countries, obtaining genuine informed consent becomes extremely challenging. This paper examines how a quick and relatively simple intervention (Rapid Assessment) can influence the design and implementation of informed consent processes in the context of biomedical research involving poor, socially stigmatized and illiterate communities in a developing country. The paper goes on to discuss the effect of social, cultural, and economic factors identified by the intervention in a particular context and demonstrates how knowledge of these influences helped to develop a socially relevant and practical consent process prior to conducting a programme of community based genetic research. The paper concludes that this intervention is an effective and economical means by which to ensure the efficacy and ethical integrity of consent processes when recruiting participants to new research sites, even within countries with which researchers are already acquainted."